A Comparative Study of Regulatory Registration Procedure of Nutraceuticals in India, Canada and Australia

Abstract

"Nutraceuticals” are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as “foods for special dietary uses or functional foods or health supplements". In Canada Nutraceuticals are known as Natural health Products. In Australia, traditional, herbal, natural and alternative medicines and remedies are referred to as 'complementary medicines'. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims. In Canada Product licensing, Site licensing, GMP, Adverse drug reporting, Clinical trials & Health claims. And in Australia Product licensing, GMP, Site licensing, Labelling & Helath claims are required.